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Completed

NCT Number: NCT05045560

Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020)

Objective :

Anorectal malformations (ARMs) are part of a spectrum of malformations due to an abnormal separation between the urogenital and digestive tracts during embryonic life. The prevalence of ARM is 1/2000 - 1/5000 live births, making it a relatively common malformation.

The impact of an ARM depends mainly on the type of malformation, which can be difficult to evaluate in the antenatal period, and whether it is isolated or associated (50-80%) with other malformations or genetic syndromes. Only 1 to 16% of ARMs are diagnosed in the antenatal period.

The objective of this study is to compare cases of prenatal diagnosis of ARM, cases of postnatal diagnosis of ARM with other antenatal ultrasound abnormalities, and those with normal antenatal ultrasound, in terms of management and functional prognosis, to identify ways to improve prenatal counseling.

Materials and methods :

In this retrospective monocentric study, the investigators have included all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier. The Krickenbeck classification was used to classify the ARMs and to assess the functional prognosis.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • fetuses and newborns born between January 2010 and September 2020 with anorectal malformations
  • diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier.

Exclusion criteria

  • foreign-born patient
  • anorectal malformation associated with an abdominal wall defect

Treatment and study plan

Primary outcomes

  1. Number of ante or post-natal diagnosispremolars

    Time frame: 1 day

    Number of ante or post-natal diagnosis

Secondary outcomes

  1. Number of with or without associated antenatal anomalies

    Time frame: 1 day

    Number of with or without associated antenatal anomalies

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020) : Why and How to Improve Antenatal Counseling ?

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2021
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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